Ptw-New York Corp.: FDA clearances and approvals
Ptw-New York Corp. has 8 FDA 510(k) clearances (first 1995, latest 2006), across 3 product codes in 1 review panel. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | 2 |
| KXK | Source, Brachytherapy, Radionuclide | 1 | 1 |
Review panels
- Radiology (8)
Most recent Ptw-New York Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062817 | PTW DAVID IMRT QC VERIFICATION SYSTEM | IYE | 2006-11-22 | 63 |
| K010705 | OPTIDOS | KXK | 2003-03-11 | 732 |
| K010916 | PTW DOSIMETRY DIODE, T60008 | IYE | 2001-06-20 | 85 |
| K972212 | 0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER | LHN | 1997-09-10 | 90 |
| K972211 | MULTIDOS, QC6PLUS | LHN | 1997-09-10 | 90 |
| K961208 | 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER | IYE | 1996-06-17 | 83 |
| K954165 | PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM | IYE | 1995-12-05 | 91 |
| K951764 | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR | IYE | 1995-10-07 | 173 |
Recalls
openFDA lists no recalls under a recalling firm named Ptw-New York Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ptw-New York Corp. have?
Ptw-New York Corp. has 8 FDA 510(k) clearances (first 1995, latest 2006), across 3 product codes in 1 review panel.
How long does FDA take to clear Ptw-New York Corp.'s 510(k)s?
The median time from FDA receipt to decision across Ptw-New York Corp.'s cleared 510(k)s is 90 days.
What devices does Ptw-New York Corp. make?
Its most frequent FDA product codes are IYE (Accelerator, Linear, Medical, 5); LHN (System, Radiation Therapy, Charged-Particle, Medical, 2); KXK (Source, Brachytherapy, Radionuclide, 1).
Has Ptw-New York Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ptw-New York Corp. Related entities may recall under other names.
Next steps
- See all 8 Ptw-New York Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Ptw-New York Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.